(164 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the cervical fusion cages, with no mention of AI or ML technology.
Yes
The device is described as an interbody fusion device intended for spinal fusion procedures in patients with degenerative disc disease, which aims to treat a medical condition and restore function.
No
The device is described as an interbody fusion device intended for spinal fusion procedures, providing mechanical support. There is no mention of it being used to diagnose conditions or generate diagnostic information.
No
The device description explicitly states the device is comprised of "cervical interbody spacers" manufactured from PEEK and tantalum, which are physical implants, not software. The performance studies also describe mechanical testing of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The SPICCA Cervical Fusion Cages are physical implants designed to be surgically placed in the cervical spine to provide structural support during spinal fusion. They are not used to test samples from the body.
- Performance Studies: The performance studies described are mechanical tests on the device itself (static and dynamic testing, subsidence), not tests on biological samples.
Therefore, the SPICCA Cervical Fusion Cages fall under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SPICCA Cervical Fusion Cages are cervical interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is intended to be used in combination with an anterior cervical plating system.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The SPICCA Cervical Fusion Cages system is an intervertebral spinal fusion system comprised of cervical interbody spacers which are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant includes a variety of footprints, heights, and lordosis options to optimize patient fit. All implants are manufactured from PEEK per ASTM F560 with tantalum (ASTM F2026) markers. All the implants are offered with a titanium powder coating per ASTM F1580 and some of the implants are also offered without the coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2/C3 disc space to C7/T1 disc space
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SPICCA Cervical Fusion Cages has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077
- Static torsion per ASTM F2077
- Subsidence per ASTM F2267
- Dynamic axial compression per ASTM F2077
- Dynamic compression shear per ASTM F2077
- Dynamic torsion per ASTM F2077
The results of this non-clinical testing show that the strength of the SPICCA Cervical Fusion Cages is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K210044, K200458, K172320, K193369
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
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August 14, 2023
Southern Medical (Pty) Ltd % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K230607
Trade/Device Name: SPICCA Cervical Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 19, 2023 Received: July 19, 2023
Dear Nathan Wright:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230607
Device Name SPICCA Cervical Fusion Cages
Indications for Use (Describe)
SPICCA Cervical Fusion Cages are cervical interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is intended to be used in combination with an anterior cervical plating system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
| Submitter's Name: | Southern Medical (Pty) Ltd |
|---|---|
| Submitter's Address: | 55 Regency Drive |
| Route 21 Corporate Park | |
| Irene, Centurion, Gauteng 0178 | |
| South Africa | |
| Submitter's Telephone: | +27 12 667 6243/4 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | March 3, 2023 |
| Trade or Proprietary Name: | SPICCA Cervical Fusion Cages |
| Common or Usual Name: | Interbody Fusion Device, Cervical |
| Classification: | Class II per 21 CFR §888.8030 |
| Product Code: | ODP |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SPICCA Cervical Fusion Cages system is an intervertebral spinal fusion system comprised of cervical interbody spacers which are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant includes a variety of footprints, heights, and lordosis options to optimize patient fit. All implants are manufactured from PEEK per ASTM F560 with tantalum (ASTM F2026) markers. All the implants are offered with a titanium powder coating per ASTM F1580 and some of the implants are also offered without the coating.
INDICATIONS FOR USE:
SPICCA Cervical Fusion Cages are cervical interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is intended to be used in combination with an anterior cervical plating system.
4
TECHNOLOGICAL CHARACTERISTICS:
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Structural support mechanism ●
Predicate Devices
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Product
Code | Predicate
Type |
|----------------|-----------------------------------------------|-------------------------|-----------------|-------------------|
| K210044 | Crystal Spinal System | Spinal Elements, Inc. | ODP | Primary |
| K200458 | Tailored-C Cervical Interbody Fusion System | BeSpoke Technologies | ODP | Additional |
| K172320 | Neurostructures Cavetto® Cervical Cage System | NeuroStructures, Inc. | ODP | Additional |
| K193369 | SureMAX™ Family of Cervical Spacers | Additive Implants, Inc. | ODP | Additional |
PERFORMANCE DATA:
The SPICCA Cervical Fusion Cages has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077 ●
- Static torsion per ASTM F2077 ●
- Subsidence per ASTM F2267 ●
- Dynamic axial compression per ASTM F2077
- Dynamic compression shear per ASTM F2077 ●
- . Dynamic torsion per ASTM F2077
The results of this non-clinical testing show that the strength of the SPICCA Cervical Fusion Cages is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION:
The overall technology characteristics and mechanical performance data lead to the conclusion that the SPICCA Cervical Fusion Cages are substantially equivalent to the predicate device.